A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

Fudan University

Status and phase: Completed; Phase 3

Conditions: Stage III Esophageal Squamous Cell Carcinoma

Treatments: Radiation: Radiotherapy; Drug: Paclitaxel and Carboplatin; Drug: Paclitaxel and Fluorouracil; Drug: Paclitaxel and Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02459457

ESO-Shanghai 2

Details and patient eligibility

About

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

Enrollment: 321 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

To be eligible for this study, patient must fulfill all of the following criteria:

1. Histologically confirmed esophageal squamous cell carcinoma

2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification

3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.

4. Aged 18-75 years

5. Adequate organ functions

   1. White blood cell (WBC) ≥3×109⁄L
   2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
   3. Hemoglobin (Hb) ≥10g⁄dl
   4. Platelet (Plt) ≥100×109⁄L
   5. Total bilirubin <1.5 upper limit of normal (ULN)
   6. Aspartate transaminase (AST) ≤2.5 ULN
   7. Alanine aminotransferase (ALT) ≤2.5 ULN
   8. Creatinine ≤1.5 ULN

6. ECOG PS of 0-2

7. Life expectancy ≥3 months

8. Written informed consent

Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.

1. Esophageal perforation or hematemesis
2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
3. Received thoracic, abdominal or craniocerebral surgery within 30 days
4. Enrolled in other clinical trials within 30 days
5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
6. Severe psychiatric disease
7. Pregnancy, lactation or unwillingness to adopt contraception
8. Drug addiction
9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1
11. History of radiotherapy in the planning area
12. Other ineligible conditions according to researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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321 participants in 3 patient groups

Paclitaxel and Cisplatin (TP)

Active Comparator group

Description:

Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\*4

Treatment:

Drug: Paclitaxel and Cisplatin

Radiation: Radiotherapy

Paclitaxel and Fluorouracil (TF)

Active Comparator group

Description:

Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\*2

Treatment:

Radiation: Radiotherapy

Drug: Paclitaxel and Fluorouracil

Paclitaxel and Carboplatin（TC）

Active Comparator group

Description:

Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w\*2

Treatment:

Radiation: Radiotherapy

Drug: Paclitaxel and Carboplatin